Friday, March 11, 2011

Woohoo! Benlysta's approved!

After more than 52 years, the FDA has approved a new drug to treat lupus, a drug that is, in fact, the first drug EVER to be specifically developed to treat the disease. What a milestone!

On Wednesday, March 9th, the FDA approved Benlysta for the treatment of systemic lupus. The drug came out of Human Genome Sciences, Inc., which is located right here in Rockville, Maryland. I had the pleasure of passing on a copy of my book to one of the doctors working on the Benlysta team at HGSI. Maybe I should get a few more copies in circulation among other pharmaceutical companies to provide the same motivation!

Looks like the drug is going to be in the hands of doctors and patients by the end of the month. In the meantime, here are some commonly asked questions about the drug. Read up now so you'll be informed when the drug comes a-calling!

What is BENLYSTA?BENLYSTA is a human monoclonal antibody, which is a type of protein made in the laboratory that is developed to find and attach to only one type of substance in the body.

How does BENLYSTA work?BENLYSTA is a human monoclonal antibody that specifically recognizes and blocks the biological activity of B-lymphocyte stimulator, or BLyS® (pronounced bliss), a naturally occurring protein which was discovered by scientists at Human Genome Sciences (HGS). Elevated levels of BLyS prolong the survival of B cells which can contribute to the production of autoantibodies – antibodies that target the body’s own tissues. Studies have shown that BENLYSTA can reduce autoantibody levels and help control autoimmune disease activity.

What does an FDA approval of BENLYSTA mean for people with lupus?BENLYSTA represents a breakthrough in the treatment of lupus. BENLYSTA is the first drug approved to treat lupus in more than 50 years AND is the first drug developed specifically for lupus since the disease was discovered more than a century ago! Successful treatment of lupus will require an arsenal of safe, effective, and tolerable treatments. The approval of BENLYSTA is a significant first step toward reaching that goal.

What makes BENLYSTA different from other lupus treatments?BENLYSTA is the FIRST FDA-approved medication specifically designed for the treatment of lupus. BENLYSTA targets specific immune cells, rather than the blanket approach of other therapies which suppress the entire immune system. Currently approved medications for lupus are borrowed from other diseases and conditions; other treatments are used off-label, which means they were never approved by the FDA for lupus. Many of these treatments have serious and devastating side effects.

These drugs include high doses of steroids, antimalarial medications, immunosupressive drugs, and organ-rejection drugs.

Who should take BENLYSTA? Will it work for everyone?Each person with lupus is unique, and BENLYSTA will not be an option for everyone. You will need to discuss with your doctor if BENLYSTA may be an appropriate treatment option for you.

BENLYSTA is approved for the treatment of adult patients with active, autoantibody-positive systemic lupus erythematosus (SLE) who are receiving standard therapy.

The label for BENLYSTA includes the following limitations of use: The efficacy of BENLYSTA has not been evaluated in patients with severe active lupus nephritis or severe active central nervous system lupus, and has not been studied in combination with other biologics or intravenous cyclophosphamide. Use of BENLYSTA is therefore not recommended in these situations. Nor has BENLYSTA been approved for use in children. More clinical studies are needed.

What side effects have been found with BENLYSTA?The most commonly reported adverse reactions with BENLYSTA were nausea, diarrhea, pyrexia, nasopharyngitis, bronchitis, insomnia, pain in extremity, depression, migraine, and pharyngitis.

How is BENLYSTA administered?BENLYSTA is administered through an IV (intravenous) infusion directly into the vein.

How much does BENLYSTA cost?We understand that there are going to be many questions, particularly around the affordability and accessibly of BENLYSTA, and the LFA will continue to address these important issues, and provide information as it is available.

Why has it taken so long to find a treatment for lupus?Lupus is a complex disease. It can affect multiple organ systems and symptoms can range in severity from one day to the next. Also, lupus affects each person differently, with varying responses to treatment. The complexity and heterogeneity of the disease presents challenges in evaluating potential new therapies. With each research study, regardless of the outcome, there are new discoveries that help pave the way for new therapies.

I am proud to be a part of the study that has been going on trial for many years for Benlysta. Benlysta has helped me to improve lupus symptoms. I originally signed up for the treatment trial 5 years ago not expecting much but as time went on i noticed what a difference this treatment had made in my life. I found myself being more active, less stressed and lupus flare ups decreased. It gave hope to me that perhaps in time a definite cure will be found for lupus.

A cure that will cost $20,000 a year? So you'd have to have over a million dollars to get it for your lifetime. Our doctors sent pictures of my sister and her case to see what they can do, it's been a year and nothing. My sister has the best doctor in the city and people still walk up to her and say "omg, what happened to your face?" I'll save my optimism until they make something affordable.

BUY THE BOOK

Sara Gorman

In 2001, I was diagnosed with systemic lupus, at the age of 26. I had been married less than 6 weeks and was at a highpoint in my career in television production. While I fought to keep hold of the life I'd known - demanding, yet fulfilling career, busy social life, packed vacation schedule - after four years of running my body into the ground, I realized I was fighting life, not living it. Thus, I downshifted almost every aspect of my life. I let go of my career and made it my number one priority to get myself back in good health. I'm proud to say that I've reached my goal, but work each day to maintain that healthy lifestyle. despite lupus. My book details the steps it took to reach that goal. A native of Indiana and graduate of the University of Notre Dame, I reside in Alexandria, Virginia with my husband, two young daughters, and pug dog.